Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men
Information source: Clarus Therapeutics, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypogonadism
Intervention: Testosterone undecanoate (TU) (Drug); TU + testosterone enanthate (TE) (Drug); Testosterone undecanoate (TU) (Drug); TU + testosterone enanthate (TE) (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Clarus Therapeutics, Inc. Official(s) and/or principal investigator(s):
Ronald S Swerdloff, M.D., Principal Investigator, Affiliation: Los Angeles Biomedical Research Institute
Gregory Flippo, M.D., Principal Investigator, Affiliation: Alabama Clinical Therapeutics, Inc.
Steven J. Kulback, M.D., Principal Investigator, Affiliation: Alabama Internal Medicine
Sherwyn Schwartz, M.D., Principal Investigator, Affiliation: dgd Research, Inc.
Overall contact:
Sandy Faulkner, RN, Phone: 847-562-4300, Ext: 202, Email: sfaulkner@clarustherapeutics.com
Summary
The purpose of this pharmacokinetic study is to determine whether oral testosterone ester
formulations can be used effectively to treat men with low testosterone.
Clinical Details
Official title: Phase II, Repeat Dose, Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men
Study design: Treatment, Non-Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Serum testosterone Cmax, Tmax, Cavg and AUC
Secondary outcome: Serum DHT, E2, TU, and TE pharmacokinetic parameters
Eligibility
Minimum age: 18 Years.
Maximum age: 68 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Male, ages 18-68
- Serum total testosterone less than or equal to 275 ng/dL
Exclusion Criteria:
- Significant intercurrent disease of any type, in particular, liver, kidney or heart
disease, uncontrolled diabetes mellitus or psychiatric illness.
- Abnormal prostate digital rectal examination, elevated PSA, AUA symptom score of >15,
and/or history of prostate cancer.
- Hematocrit of <35 or >50%
- BMI >36
- Serum transaminases > 2 times upper limit of normal or serum bilirubin > 2. 0 mg/dL
Locations and Contacts
Sandy Faulkner, RN, Phone: 847-562-4300, Ext: 202, Email: sfaulkner@clarustherapeutics.com
Alabama Clinical Therapeutics, Birmingham, Alabama 35235, United States; Recruiting
Lisa Palmedo, Phone: 205-833-2228
Gregory Flippo, M.D., Principal Investigator
Alabama Internal Medicine, Birmingham, Alabama 35235, United States; Recruiting
Carla Honeycutt, Phone: 205-838-3200
Steven J. Kulback, M.D., Principal Investigator
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Los Angeles, California 90502, United States; Recruiting
Berenice Lomeli, Phone: 310-222-1865
Ronald S Swerdloff, M.D., Principal Investigator
dgd Research, Inc., San Antonio, Texas 78229, United States; Recruiting
Joseph Kennard, Phone: 210-426-3719
Sherwyn L. Schwartz, M.D., Principal Investigator
Additional Information
Starting date: June 2008
Ending date: December 2008
Last updated: June 10, 2008
|
